The Advanced level of the Aleph Design Controls course track is for professionals who already have the 21 CFR §820.30 vocabulary covered at orientation depth and need to develop the applied skills the medical-device industry expects: authoring a Design and Development Plan that defines scope, responsibilities, deliverables, and reviews; authoring Design Input that captures user needs, intended use, and applicable regulatory and standards requirements; authoring Design Output that satisfies the Design Input with bidirectional traceability; governing Design Review with cross-functional independent reviewers; planning Design Verification per §820.30(f) and Design Validation per §820.30(g) including human-factors validation aligned with IEC 62366-1; planning Design Transfer per §820.30(h); handling Design Changes per §820.30(i) with impact assessment and risk-management linkage; and compiling the Design History File per §820.30(j) as an auditable record of the design effort.

This 32-hour Professional Certificate Course builds directly on the 16-hour Introductory level (`RAQ-610-I`). It does not repeat the §820.30 vocabulary orientation. Where the Introductory level identifies Design Input and Design Output, the Advanced level authors both on a chosen device with documented bidirectional traceability. Where the Introductory level distinguishes Verification from Validation, the Advanced level plans both on a chosen device. The course is organized around a chosen-device cumulative deliverable arc — the participant selects a device in Module 1, builds Design Controls content on it across Modules 2 through 8, and integrates everything into a Design History File in the Module 9 capstone course exercise.

Graduates of the Advanced course are positioned for senior applied work in Design Assurance, Quality, and Regulatory roles at medical-device, IVD, and combination-product manufacturers; at consultancies serving manufacturers on Design History File construction and audit readiness; and at organizations responding to FDA Warning Letters tied to Design Controls findings. The compiled Design History File produced during the course is a portfolio-grade artifact.

Participants who meet the course completion requirements receive a Certificate of Completion issued by Aleph University.